Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabilitation in Subchronic Stroke: A Feasibility Study

NCT07211672 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-10-08

No results posted yet for this study

Summary

The goal of this interventional study is to evaluate the effect of multichannel functionnal electrical stimulation for subchronic stroke gait rehabilitation. The main questions it aims to answer are:

* Does this new therapy help improve walking speed?
* Evaluate other aspects of therapeutic effectiveness such as different aspects of walking endurance, mobility, postural instability and autonomy.
* Evaluate physiological aspects of autonomous gait such as spasticity, muscle strength and motor and sensorimotor recovery.
* Evaluate the acceptability of this new therapy and its effect on quality of life.

Conditions

  • Stroke Sequelae
  • Stroke ( 3 Months After Onset)

Interventions

DEVICE

Multichannel functionnal electrical stimulation

The participants completed 24 gait rehabilitation sessions over the course of 8 to 12 weeks. Each session lasted between 30 minutes and 1 hour. A minimum of 2 days seperated two consecutive sessions. The number of sessions was used for standardization of the protocol instead of duration of treatment. Four evaluations were completed throughout the protocol. Baseline evaluation(V1) was completed between 2 and 7 days before the first rehabilitation session. Intermediate evaluation(V2) was completed between 2 and 7 days after the 12th rehabilitation session, in other words 4 to 6 weeks after the baseline evaluation (V1) . Post-treatment evaluation(V3) was completed between 2 and 7 days after the 24th rehabilitation session, in other words 8 to 12 weeks after the baseline evaluation (V1). Follow-up evaluation(V4) was completed 2 months(60 days) after the 24th rehabilitation session, in other words 16 to 20 weeks after the baseline evaluation (V1).

Sponsors & Collaborators

  • Kurage SAS

    collaborator OTHER
  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER
  • Clinique Synapse - Réadaptation & Vie Active

    collaborator UNKNOWN
  • TOPMED

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-09-01
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07211672 on ClinicalTrials.gov